Arbios Systems, Inc.
(OTC Bulletin Board: ABOS), provided its clinical trial strategy for
the SEPET(TM) Liver Assist Device including information regarding a
pre-pivotal phase meeting with the US Food and Drug Administration (FDA).
In a meeting held between Arbios and the FDA's Office for Device Evaluation
and Research (ODE), the FDA indicated that, pending receipt of a final
report, SEPET(TM) has met the required feasibility trial objectives and
Arbios may advance its clinical development program to the pivotal phase.
In response to the presentation of a pivotal trial design, the FDA provided
the Company with comment and further indicated that a single pivotal study
may be acceptable to the FDA, subject to a submission of a full clinical
protocol to include additional information required in an Investigational
Device Exemption (IDE) application. Arbios intends to file this information
for review in the coming weeks, as a potential final step toward FDA
authorization of a pivotal clinical trial for SEPET(TM).
"We are pleased with the discussion at our recent meeting with the FDA
regarding our SEPET(TM) Liver Assist Device," commented Shawn Cain, Interim
President and Chief Executive Officer of Arbios. "Following the results of
our feasibility clinical trial, the FDA review group said that SEPET(TM)
could advance into a multicenter pivotal clinical trial. We appear to be on
track for near term initiation of a pivotal registration trial of SEPET(TM)
in the US."
We expect the proposed pivotal clinical trial would enroll 80 patients
in the principal randomized, controlled phase of the study, targeted to
achieve the primary endpoint of the trial, which is a clinically
significant reduction in hepatic encephalopathy. Patients receiving
SEPET(TM) treatment plus standard medical care would be compared to control
patients receiving treatment with standard medical care alone, with 1:1
randomization between the two groups. An adaptive design feature,
increasingly common in FDA product approval trials, would permit the size
of the trial to be increased after enrollment of the first 80 patients if
the primary efficacy endpoint has not yet reached statistical significance
but has shown a positive trend. A further and final potential extension of
the trial would also be permitted to achieve statistical significance of
one or more secondary endpoints of the trial relating to clinical,
functional, and reimbursement advantages for SEPET(TM)-treated patients.
In parallel with the US-oriented pivotal clinical trial of the
SEPET(TM) Liver Assist Device, Arbios intends to advance the product toward
European market approval under the CE Mark. Arbios believes that such
registration of SEPET(TM) could be accomplished significantly earlier than
registration in the US, because a randomized, controlled trial is
customarily not required under the European Medical Device Directives.
Arbios plans to involve several leading European medical centers in the
pivotal trial, so that the results of the trial will be relevant to both US
and European patients and may be used to support medical payor (both
private sector and government) coverage in both regions.
About Arbios' SEPET(TM) Liver Assist Device
The SEPET(TM) Liver Assist Device is a sterile, disposable cartridge
containing microporous hollow fibers with proprietary permeability
characteristics. When a patient's blood is passed through these fibers,
blood plasma components of specific molecular weights are expressed through
the micropores, thereby cleansing the blood of harmful impurities (e.g.,
hepatic failure toxins as well as various mediators of inflammation and
inhibitors of liver regeneration). These substances would otherwise
progressively accumulate in the patient's bloodstream during liver failure,
causing hypotension, increasing risk of sepsis development and accelerating
damage to the liver, lungs and other organs, including the brain and
kidneys, and suppressing the function and regeneration of the liver.
SEPET(TM) is designed for use with standard blood dialysis systems
available in hospital intensive care units.
According to the American Liver Foundation, chronic liver disease is
the tenth leading cause of death in the US, resulting in approximately $10
billion in annual healthcare costs. There is currently no satisfactory
therapy available to treat patients in liver failure, other than
maintenance and monitoring of vital functions and keeping patients stable
through provision of intravenous fluids and blood products, administration
of antibiotics and support of vital functions, such as respiration.
About Arbios Systems
Arbios Systems, Inc. is developing proprietary medical devices and
cell- based therapies to enhance the survival of millions of patients each
year who experience, or are at risk for, life-threatening episodes of liver
failure. The Arbios product candidate portfolio includes the SEPET(TM)
Liver Assist Device, a novel blood purification therapy that provides
enhanced "liver dialysis," and the HepatAssist(TM) Cell-Based Liver Support
System, a bioartificial liver that combines blood detoxification with liver
cell therapy to replace whole liver function in patients with the most
severe forms of liver failure. For more information on the Company, please
visit arbios.
This press release contains forward-looking statements, including, but
not limited to, statements regarding the Company's expectations as to the
path forward for the clinical development of SEPET(TM), including the
expected design of the pivotal trial of SEPET(TM). The forward looking
statements contained in this press release involve risks and uncertainties
that could cause actual events or results to differ materially from the
events or results described in the forward-looking statements, including,
but not limited to, risks or uncertainties related to the goals and results
of clinical trials, the timing and outcome of the FDA's review of the
revised protocol for the proposed pivotal trial of SEPET(TM), compliance
with regulatory requirements, labeling of the Company's products, the need
for subsequent substantial additional financing to complete clinical
development of its products, future markets and demand for the Company's
products, and Arbios' ability to successfully market its products and
technologies. These statements represent the judgment of Arbios' management
as of this date and are subject to risks and uncertainties that could
adversely affect the Company. Arbios cautions investors that there can be
no assurance that actual results or business conditions will not differ
materially from those projected or suggested in such forward-looking
statements. Please refer to our Annual Report on Form 10- KSB for the
fiscal year ended December 31, 2006, and to our subsequent Quarterly
Reports on Form 10-QSB, for a description of risks that may affect our
results or business conditions. The Company does not undertake any
obligation to publicly release the result of any revisions to such forward-
looking statements that may be made to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events
except as required by law. SEPET(TM) and HepatAssist(TM) are trademarks of
Arbios Systems, Inc.
Arbios Systems, Inc.
arbios